Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit
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- NDC Code(s): 0280-0069-01
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a
doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
· hives · facial swelling · asthma (wheezing) · shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this product
● take more or for a longer time than directed
Sore throat warning: If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
● if you are allergic to aspirin or any other pain reliever/fever reducer
● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
● if you have ever had an allergic reaction to this product or any of itsingredients
● in children under 12 years of age
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have
- asthma •thyroid •disease diabetes
- cough that occurs with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- cough comes back or occurs with rash or headache that lasts. These
- could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
ACTIVE INGREDIENT
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant
Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine
Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant
*nonsteroidal anti-inflammatory drug
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling ·
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- artake a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have
- asthma
- diabetes
- thyroid disease
- glaucoma
- cough that occurs with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma,or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for
- gout
- diabetes
- arthritis
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- cough comes back or occurs with rash or headache that lasts. These
- could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
Alka-Seltzer Plus®
SEVERE COLD
DAY/CITRUS
NIGHT LEMON
POWERFAST FIZZ™
DAY NON-DROWSY
ASPIRIN (NSAID)/Pain Reliever - Fever Reducer
DEXTROMETHORPHAN HBr/Cough Suppressant
PHENYLEPHRINE BITARTRATE/Nasal Decongestant
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NEW NIGHT DOSING DIRECTIONS
NIGHT
Aspirin (NSAID)/Pain Reliever-Fever Reducer
Dextromethorphan HBr/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine Bitartrate/Nasal Decongestant
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0069 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0069-01 1 in 1 CARTON; Type 0: Not a Combination Product 08/05/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 12 POUCH 12 Part 2 8 POUCH 8 Part 1 of 2 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY
asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCRALOSE (UNII: 96K6UQ3ZD4) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/05/2021 Part 2 of 2 ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ
aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0068 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) DIMETHICONE (UNII: 92RU3N3Y1O) CALCIUM SILICATE (UNII: S4255P4G5M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON, LEMON Imprint Code ASP;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/05/2021 Labeler - Bayer HealthCare LLC. (112117283)